APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss

FDA classification

FDA Class 2 ·Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss

Fora Comfort 2 in 1 TD-3250C Blood Glucose and Blood Pressure Monitoring System

FDA registration

TAIDOC TECHNOLOGY CORPORATION·3 products·🇹🇼 Taiwan

BIOTINIDASE (BTD) ELISA

FDA registration

MONOCENT INC.·1 product·🇺🇸 United States

BIOTINIDASE (BTD) ELISA

FDA registration

MONOCENT INC.·1 product·🇺🇸 United States

BRAZEN GOODS INC.

FDA registration

BRAZEN GOODS INC.·1 product·🇺🇸 United States

KAREX INDUSTRIES SDN BHD

FDA registration

KAREX INDUSTRIES SDN BHD·1 product·🇲🇾 Malaysia

FOUR D RUBBER CO LTD

FDA registration

FOUR D RUBBER CO LTD·1 product·🇬🇧 United Kingdom

Harmony Latex Dams Harmony Polyisoprene Dams

FDA registration

PAMCO DISTRIBUTING INC.·1 product·🇨🇦 Canada

Satin Dams

FDA registration

GLOBAL PROTECTION CORP.·1 product·🇺🇸 United States

SANCTUARY HEALTH SDN BHD

FDA registration

SANCTUARY HEALTH SDN BHD·1 product·🇲🇾 Malaysia

Anthogyr ATD AUTOMATIC BRIDGE REMOVER

FDA registration

ANTHOGYR·1 product·🇫🇷 France

GENSPEED Biotech

Manufacturer

🇦🇹 Austria·1 Basic UDI-DI·1 Device·QMD Services GmbH, QMD Services GmbH, QMD Services GmbH, and QMD Services GmbH

NANJING YINUOJI MEDICAL TECHNOLOGY CO., LTD.

FDA registration

NANJING YINUOJI MEDICAL TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

CoaguSense Inc.

Manufacturer

🇺🇸 United States·4 Basic UDI-DIs·4 Devices·BSI Assurance UK Ltd, BSI Assurance UK Ltd, and BSI Assurance UK Ltd

Ortho Cape

Manufacturer

🇫🇷 France·82 Basic UDI-DIs·82 Devices·HTCert (Health Technology Certification Ltd), HTCert (Health Technology Certification Ltd), HTCert (Health Technology Certification Ltd), and HTCert (Health Technology Certification Ltd)

Quick-Start

FDA registration

INNOVATE ORTHOPAEDICS LTD.·1 product·🇬🇧 United Kingdom

Quick-Start

FDA registration

INNOVATE ORTHOPAEDICS LTD.·1 product·🇬🇧 United Kingdom

Smit Medimed Private Limited

Manufacturer

🇮🇳 India·10 Basic UDI-DIs·10 Devices·1 Importer·HTCert (Health Technology Certification Ltd) and HTCert (Health Technology Certification Ltd)

SOFNOLIME

FDA registration

MOLECULAR PRODUCTS LTD·1 product·🇬🇧 United Kingdom